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September, 2025 | Equitox
Medicines and the environment: the EMA’s new framework

Medicines and the environment: the EMA’s new framework

3 Sep 2025

The 2024 revision of the EMA guideline on the environmental risk assessment (ERA) of human medicinal products (EMA, 2024)[1] replaces practice-based approaches with a clear, harmonised methodology. It retains the tiered approach introduced in 2006, clarifies how it...
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